N/A
N=51
Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
Vertebral Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT05467540 ↗Enrolled (actual)
51
Serious AEs
25.5%
Results posted
Nov 2025
Primary outcome: Primary: Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires — 3.4; 65.2 points on a numeric scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spinery System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Axon srl
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires |
3.4; 65.2 | — |
| PRIMARY Number and Percentage of Participants Who Successfully Completed the Spinery® RF Ablation Procedure |
51 | — |
Summary
The SPARTA study (Spinery® Radiofrequency Ablation Device Study) is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety, performance, and efficacy of the Spinery® RF Generator and its sterile single-use accessories for the palliative treatment of painful bone metastases.
Adult patients with metastatic lesions involving the vertebral bodies, sacrum, iliac crest, or peri-acetabulum who were not candidates for, or had failed, standard therapies underwent percutaneous radiofrequency ablation with the investigational device.
A total of 52 participants were enrolled across five Italian centers and were assessed at baseline, post-procedure, and during follow-up visits at 1, 3, and 12 months.
Endpoints include evaluation of pain reduction, quality of life, usability, and procedural safety.
Eligibility Criteria
Inclusion Criteria
- Patients with painful metastatic malignant lesions involving bone;
- Patients, candidates to standard therapy, in which the RF ablation can be performed in combination with the Standard Therapy in accordance with the Investigator's indications;
- Patients who have failed, not candidates or refuse Standard Therapy (chemotherapy or radiotherapy);
- Patients with metastatic tumor size compatible with the expected ablation dimensions as reported for SPINERY devices in the IFU;
- Patients with localized pain resulting from not more than two sites of symptomatic metastatic disease
- Patients that do not have evidence of impending fracture
- Patients with metastatic lesions targeted for treatment located in the thoracic and/or lumbar vertebral body(ies), peri-acetabulum, iliac crest, and/or sacrum - no restrictions on location of lesion;
- Patients with BPI-Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
- Patients with Karnofsky score ≥ 40 at enrollment
- Patients willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
- Patients at least 18 years old at the time of informed consent
Exclusion Criteria
- Patients implanted with heart pacemaker or other implanted electronic device
- Patients with previous mechanical bone stabilization in the vertebral body to be treated
- Use of SPINERY in vertebral body levels C1-C7
- Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone.
- Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection.
- Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise.
- Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression.
- Fractures due to prostatic cancer or other osteoblastic metastases to the spine. Metastatic lesions originating in the prostate that are osteolytic or of mixed origin are eligible for the study.
- Pregnant, breastfeeding, or plan to become pregnant during the study duration.
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
- Any condition that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation.
Data sourced from ClinicalTrials.gov (NCT05467540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.